An observational study in Tuberculosis, sponsored by QIAGEN Gaithersburg, Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-01.
Sponsored by QIAGEN Gaithersburg, Inc · Observational
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
To compare the specificity of the CST001 assay to the QFT Gold Test in low TB exposure risk subjects and non-tuberculosis mycobacterial infections.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 268 is close to the median of 250 across 421 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →QIAGEN Gaithersburg, Inc is the lead sponsor of 26 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who have either low-exposure rist to tuberculosis or have non-tuberculous mycobacterial infections
Low-exposure Risk Group
Inclusion Criteria:
Exclusion Criteria:
Non-tuberculous mycobacterial infection Group
Inclusion Criteria:
Exclusion Criteria:
Group tested with CST_001
Device: CST_001
Group tested with CST_001
Device: CST_001
Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives
To compare the clinical specificity of the CST001 assay to the QuantiFERON-TB Gold test in low TB exposure risk subjects and non TB infected subjects based on an assessment of known risk factors. These subjects had no identified risk factors of TB infection.
Time frame: 1 day (At time of enrollment)
| Milestone | Non TB Infection | Low Exposure Risk |
|---|---|---|
| Started | 53 | 215 |
| Completed | 51 | 212 |
| Not completed | 2 | 3 |
| Withdrew: Did not meet eligibility criteria | 2 | 3 |
To compare the clinical specificity of the CST001 assay to the QuantiFERON-TB Gold test in low TB exposure risk subjects and non TB infected subjects based on an assessment of known risk factors. These subjects had no identified risk factors of TB infection.
| Participants | Non TB Infection | Low Exposure Risk |
|---|---|---|
| Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives | 49 | 208 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non TB Infection | — | 0/51 (0%) | 0/51 (0%) |
| Low Exposure Risk | — | 0/212 (0%) | 0/212 (0%) |
| Age, Categorical(Participants) | Non TB Infection | Low Exposure Risk | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 27 | 207 | 234 |
| >=65 years | 24 | 5 | 29 |
| Sex: Female, Male(Participants) | Non TB Infection | Low Exposure Risk | Total |
|---|---|---|---|
| Female | 12 | 157 | 169 |
| Male | 39 | 55 | 94 |
| Ethnicity (NIH/OMB)(Participants) | Non TB Infection | Low Exposure Risk | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 10 | 11 |
| Not Hispanic or Latino | 50 | 193 | 243 |
| Unknown or Not Reported | 0 | 9 | 9 |
| Race (NIH/OMB)(Participants) | Non TB Infection | Low Exposure Risk | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 0 | 13 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 2 |
| White | 49 | 177 | 226 |
| More than one race | 1 | 13 | 14 |
| Unknown or Not Reported | 0 | 6 | 6 |
| Region of Enrollment(Participants) | Non TB Infection | Low Exposure Risk | Total |
|---|---|---|---|
| United States | 51 | 212 | 263 |
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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QIAGEN Gaithersburg, Inc